IT IS one of America鈥檚 great ironies. The US Food and Drug Administration,
possibly the toughest regulatory agency in the world, has no power to regulate a
drug that hooks millions, then kills half its users prematurely. The dangers of
the drug, nicotine, and its delivery vehicles, cigarettes, cigars and pipes, are
well documented. Yet it remains outside FDA jurisdiction.
That may be about to change. Last week, the US Supreme Court agreed to hear
an appeal from the FDA on this very point. The decision follows years of legal
wrangling. The FDA first argued it should have control over tobacco in August
1996, in a North Carolina district court. That hearing went in the FDA鈥檚 favour,
but the decision was reversed by a court of appeal, following a challenge from
the tobacco industry. In this latest appeal, the Supreme Court鈥檚 verdict is
expected in 12 months鈥� time.
Ed Sweda, senior attorney with the Tobacco Products Liability Project, an
anti-smoking lobby group based at Northeastern University in Boston, says he
expects the court to find in favour of the FDA. This would be a huge blow for
the tobacco industry, says John Slade, an expert on addiction from the
University of Medicine and Dentistry of New Jersey, in Newark. FDA control would
mean safer cigarettes on the market, he says.
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Last month the London-based campaign group Action on Smoking and 午夜福利1000集合 (ASH)
listed dozens of devices patented by cigarette makers, including special filters
and tobacco treatment processes, that could reduce levels of key toxic
substances in cigarette smoke
(This Week, 6 March, p 4). The fact that none has
found its way into cigarettes on sale to the public is revealing, says ASH.
Clive Bates, the group鈥檚 director, suggests that companies feared that using
them would be tantamount to admitting their products were dangerous鈥攁dding
to their already considerable litigation woes in the US.
Dick Daynard, a colleague of Sweda鈥檚 at Northeastern University and the
Tobacco Products Liability Project, who has played an influential role in
litigation against tobacco firms in the US, calls the manufacturers鈥� failure to
introduce such devices 鈥渁 criminal level of negligence鈥�. But not everyone is so
severe. Slade points out that tough advertising restrictions and mandatory
health warnings on cigarette packets mean that the industry would not be allowed
to promote altered brands as 鈥渟afer鈥�. This gives them little incentive to invest
in safer cigarettes, he says.
Lucrative niche
Slade and Sweda believe companies will only produce less harmful cigarettes
when they are forced to. 鈥淚f they鈥檙e going to incorporate these devices, they鈥檒l
have to be made to do it,鈥� says Sweda. But there are signs that safer tobacco
may already be on its way, even without the strong arm of the FDA.
Star Scientific, a company in Petersburg, Virginia, with a staff of just 100,
has spotted a potentially lucrative niche in the anti-smoking market. The
company, formerly Star Tobacco, produces profitable discount brands of
cigarettes. But it is also committed to helping people stop smoking: it operates
a no-smoking policy in its premises and pays staff $500 cash bonuses if
they kick the habit. Star鈥檚 ultimate aim is to transform itself into a
manufacturer of smoking cessation devices.
The company has patented a method of removing virtually all the
tobacco-specific nitrosamines鈥攖he chemicals thought to be the biggest
cancer hazard in tobacco smoke鈥攆rom its tobacco. A microwave process kills
the bacteria in tobacco that produce nitrosamines.
Star began looking into ways of removing nitrosamines after the FDA blocked
its attempt to sell nicotine gum because it contained small amounts of the
chemicals. Strangely, though the FDA has no power over cigarettes, it does have
authority over chewing gum.
Taking the cure
The company鈥檚 spokesman and legal representative, Paul Perito, says the FDA
has been very supportive, and has even advised Star on which scientists to turn
to for help in developing its low-nitrosamine cigarette. Independent tests
carried out at Virginia Commonwealth University in Richmond show that the new
curing process slashes nitrosamine levels in smoke by more than 90 per cent and
halves levels of carbon monoxide and tar.
According to Star, one of the tobacco giants has ordered a 680-tonne batch of
the treated tobacco. The company, which Star can鈥檛 name because of a
confidentiality clause, 鈥渕ust be taking it pretty seriously if it鈥檚 ordering
that much鈥�, says Jonnie Williams, Star鈥檚 executive vice-president. He claims
that all the major cigarette manufacturers have made either direct or indirect
inquiries about Star鈥檚 product, and predicts that the safer tobacco will begin
to be used in cigarettes within 18 months. Star鈥檚 approach of reducing the harm
caused by cigarettes has the backing of some prominent anti-smoking campaigners,
including Slade and Bates.
Other advances are in the pipeline, says Jerome Jaffe, the firm鈥檚 chief
medical consultant and a former US 鈥渄rugs tsar鈥�. He hints that these may build
on the recent finding that addiction may be made worse by the presence in
cigarette smoke of chemicals called monoamine oxidase inhibitors (MAOIs), a
class of chemicals that have been used as drugs for treating depression. Jaffe
suspects that smokers may be addicted not just to nicotine but also to these
antidepressant drugs as well.
But low-nitrosamine cigarettes are first on the starting blocks. Star plans
to make the most of the Canadian government鈥檚 proposal to single out
nitrosamines as the main cancer-causing chemicals in tobacco smoke. Its federal
health ministry, 午夜福利1000集合 Canada, has proposed that information about the levels
of nitrosamines, as well as 48 other types of chemical, be printed on cigarette
packets.
Luc Ladouceur, director of the ministry鈥檚 Office of Tobacco Control in
Ottawa, cautions that we can鈥檛 yet be sure whether nitrosamine-free cigarettes
will be safer. 鈥淭here鈥檚 a good chance they would be,鈥� he says. 鈥淏ut we鈥檇 need to
do the tests.鈥� One of his advisers, Murray Kaiserman, is even more wary. By
reducing one class of chemicals, he warns, you could accidentally increase the
levels of other dangerous products. Jaffe says that he has measured levels of
key substances such as carbon monoxide in smoke from treated tobacco, and so far
has found them no higher than normal.
Kaiserman says his main concern is about how 鈥渟afer鈥� cigarettes would be
marketed. 鈥淭he major risk would be if companies were able to promote this change
as a significant improvement and oversell it,鈥� he says. He fears that this might
lead to a rise in smoking. However, a report commissioned by Ladouceur, due out
later this month, will argue largely in favour of making cigarettes tamer.
Bates sees no conflict between making cigarettes less dangerous and
discouraging people from smoking. Nicotine addiction is a long-term problem that
requires long-term solutions, he says, but that is no reason not to produce less
dangerous cigarettes in the meantime, just as we produce less dangerous and
polluting cars. 鈥淲e know we can make these products safer and that鈥檚 what we
should be doing,鈥� he says.
